Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06953518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines
Sponsor:
Qualia Life Sciences
Organization:
Study Overview
Official Title:
An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This open-label pilot study includes adults aged 45 to 79 residing in the United States. The study will last 7 days. Participants will provide blood samples via an at-home finger-prick kit at baseline and day 7 and complete electronic surveys on health indicators at baseline, and days 3 and 7. All procedures are conducted remotely, with no in-person visits, to collect real-world evidence.
Detailed Description:
Objectives Within-group changes in outcomes will be compared from baseline to the end of the study period.
Primary Outcome Measures:
Biomarkers in blood, measured using the Olink Target 48 Cytokine panel:
Tumor Necrosis Factor (TNF) Interleukin-1 Beta (IL1B) Interleukin-8 (CXCL8) Vascular Endothelial Growth Factor A (VEGFA)
Secondary Outcome Measures:
Remaining biomarkers in the Olink Target 48 Cytokine panel 36-Item Short Form Health Survey (SF-36) Frailty Index for Elders (FIFE) Depression Anxiety Stress Scale-21 (DASS-21)
Side effect profile including:
Number, type, severity, causality, and outcome of adverse events or unanticipated problems
Symptoms of aging, assessed by:
Aging Male Symptom scale Aging Female Symptom scale
Participant Details:
Study Duration per Participant: 7 days Total Number of Participants: 40
Primary Outcome Measures:
Biomarkers in blood, measured using the Olink Target 48 Cytokine panel:
Tumor Necrosis Factor (TNF) Interleukin-1 Beta (IL1B) Interleukin-8 (CXCL8) Vascular Endothelial Growth Factor A (VEGFA)
Secondary Outcome Measures:
Remaining biomarkers in the Olink Target 48 Cytokine panel 36-Item Short Form Health Survey (SF-36) Frailty Index for Elders (FIFE) Depression Anxiety Stress Scale-21 (DASS-21)
Side effect profile including:
Number, type, severity, causality, and outcome of adverse events or unanticipated problems
Symptoms of aging, assessed by:
Aging Male Symptom scale Aging Female Symptom scale
Participant Details:
Study Duration per Participant: 7 days Total Number of Participants: 40
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: